Appendectomy, LaparoscopicNCT06913205
Rectus Sheath Block and Local Wound Infiltration in Pediatric Laparoscopic Appendectomies
An observational study of Appendectomy, Laparoscopic and Pediatric Anesthesia, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic appendectomy surgeries are among the most commonly performed procedures in childhood. However, they are associated with moderate to severe postoperative pain. Regional nerve block techniques are recommended for postoperative pain management. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Appendectomy, Laparoscopic, Pediatric Anesthesia, Nerve Block/Methods
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing laparoscopic appendectomy surgery in Bursa Yuksek Ihtisas Training and Research Hospital
Who may be able to join
- Older than 8 years
- Younger than 18 years
- Minimal invasive appendectomy (3 port)
- Consent to participate
Who cannot join
- Younger than 8 years
- Older than 18 years
- Convert to open abdominal surgery
- Do not consent to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Bursa, 16110
About this study
Official title: Comparison of Regional Block Techniques Used for Postoperative Pain Management in Laparoscopic Appendectomy in Children
Laparoscopic appendectomy surgeries are among the most commonly performed procedures in childhood. However, they are associated with moderate to severe postoperative pain. Regional nerve block techniques are recommended for postoperative pain management. This research compared the two most frequently used methods: rectus sheath block and local wound infiltration.
Read the detailed description
Acute appendectomy surgeries are one of the most frequently performed surgeries in childhood. Minimally invasive (laparoscopic) surgical methods are recommended, especially in abdominal surgeries, due to rapid wound healing, rapid recovery, less bleeding, and shorter hospital stays compared to open surgery. In addition to all these advantages of laparoscopic surgeries, postoperative somatic pain is expected to be less compared to open surgeries due to the small incisions in the abdominal wall. However, when the pain severity of children who underwent laparoscopic appendectomy was evaluated using the pain scoring scale, it was seen that the median pain scores were ≥7 in 5% of the children (severe pain) and ≥4 in 25% (moderate pain). Clinical practice guidelines also recommend the use of regional anesthesia and analgesia methods as part of multimodal analgesia in the prevention of intraoperative and postoperative pain. We also routinely use regional anesthesia and analgesia methods successfully and effectively in our daily practices in our clinic.
Rectus sheath blocks, which are known to be effective in midline incisions, and local anesthetic infiltrations of the wound site, which do not require special technical knowledge about regional anesthesia, are routinely applied in our clinic in every case. Although both methods provide clinical benefits, it is unknown which one is superior to the other.
- Conditions
- Appendectomy, Laparoscopic, Pediatric Anesthesia, Nerve Block/Methods, Regional Anesthesia, Acute Pain, Postoperative
- Keywords
- laparoscopic appendectomy, pediatric anesthesia, nerve blocks, regional anesthesia, acute postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Block | Children undergoing laparoscopic appendectomy with rectus sheath blocks | |
| Local infiltration | Children undergoing laparoscopic appendectomy with local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Total acetaminophen use in the first 24 hours after surgery
Measured: Postoperative first 24 hours.
Secondary outcomes (1)
Postoperative pain scores
Pain scores will be evaluated in the postoperative period using the Wong-Baker Faces Pain Rating Scale, where zero is equivalent to no pain, and 10 indicates the worst possible pain.
Measured: Postoperative first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start25 Aug 2021
- Primary completion25 Aug 2022
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Appendectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hande Gurbuz, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913205
- Sponsor's protocol ID
- 2011-KAEK-25 2021/08-20
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sets used in this research may be made available upon reasonable request to the corresponding author.
Publications
Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.
PubMed 25581711Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
PubMed 24112856Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
PubMed 21958060Gurbuz H, Karasu D, Dogan AK, Kilicarslan N. Rectus sheath blocks for pediatric laparoscopic appendicectomy. BMC Anesthesiol. 2025 Sep 29;25(1):462. doi: 10.1186/s12871-025-03364-9.
PubMed 41023777
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regional Block Techniques Used for Postoperative Pain Management in Laparoscopic Appendectomy in Children
- ClinicalTrials.gov ID
- NCT06913205
- Acronym / sponsor ID
- 2011-KAEK-25 2021/08-20
- Conditions
- Appendectomy, Laparoscopic, Pediatric Anesthesia, Nerve Block/Methods, Regional Anesthesia, Acute Pain, Postoperative
- Keywords
- laparoscopic appendectomy, pediatric anesthesia, nerve blocks, regional anesthesia, acute postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic appendectomy surgeries are among the most commonly performed procedures in childhood. However, they are associated with moderate to severe postoperative pain. Regional nerve block techniques are recommended for postoperative pain management. This research compared the two most frequently used methods: rectus sheath block and local wound infiltration.
Detailed description
Acute appendectomy surgeries are one of the most frequently performed surgeries in childhood. Minimally invasive (laparoscopic) surgical methods are recommended, especially in abdominal surgeries, due to rapid wound healing, rapid recovery, less bleeding, and shorter hospital stays compared to open surgery. In addition to all these advantages of laparoscopic surgeries, postoperative somatic pain is expected to be less compared to open surgeries due to the small incisions in the abdominal wall. However, when the pain severity of children who underwent laparoscopic appendectomy was evaluated using the pain scoring scale, it was seen that the median pain scores were ≥7 in 5% of the children (severe pain) and ≥4 in 25% (moderate pain). Clinical practice guidelines also recommend the use of regional anesthesia and analgesia methods as part of multimodal analgesia in the prevention of intraoperative and postoperative pain. We also routinely use regional anesthesia and analgesia methods successfully and effectively in our daily practices in our clinic.
Rectus sheath blocks, which are known to be effective in midline incisions, and local anesthetic infiltrations of the wound site, which do not require special technical knowledge about regional anesthesia, are routinely applied in our clinic in every case. Although both methods provide clinical benefits, it is unknown which one is superior to the other.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Block | – | –Children undergoing laparoscopic appendectomy with rectus sheath blocks |
| Local infiltration | – | –Children undergoing laparoscopic appendectomy with local infiltration |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing laparoscopic appendectomy surgery in Bursa Yuksek Ihtisas Training and Research Hospital
Key inclusion criteria (4 listed)
- Older than 8 years
- Younger than 18 years
- Minimal invasive appendectomy (3 port)
- Consent to participate
Key exclusion criteria (4 listed)
- Younger than 8 years
- Older than 18 years
- Convert to open abdominal surgery
- Do not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analgesic consumption
Time frame: Postoperative first 24 hours.
Total acetaminophen use in the first 24 hours after surgery
1 secondary outcome
Postoperative pain scores
Time frame: Postoperative first 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 25581711Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.
- Background: PubMed 24112856Liu Y, Seipel C, Lopez ME, Nuchtern JG, Brandt ML, Fallon SC, Manyang PA, Tjia IM, Baijal RG, Watcha MF. A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. Paediatr Anaesth. 2013 Dec;23(12):1187-92. doi: 10.1111/pan.12271. Epub 2013 Sep 25.
- Background: PubMed 21958060Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.
- Derived from this study: PubMed 41023777Gurbuz H, Karasu D, Dogan AK, Kilicarslan N. Rectus sheath blocks for pediatric laparoscopic appendicectomy. BMC Anesthesiol. 2025 Sep 29;25(1):462. doi: 10.1186/s12871-025-03364-9.
- Individual participant dataSharing planned: Undecided. The data sets used in this research may be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendectomy, Laparoscopic and Pediatric Anesthesia, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: Postoperative first 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913205, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.